Biopsy system with integrated imaging

ABSTRACT

A biopsy system is disclosed that has a tissue removal system, an imaging system, an image display system and a common input console for these systems. The tissue removal system can have a mechanical tissue cutting blade or an electrosurgical cutting element and the tissue removal system is capable of handling both tissue cutting configurations. The imaging system is preferably an ultrasound imaging system and the image display system has a video screen for displaying diagnostic ultrasound images from an ultrasound probe. The common input console preferably has a touch screen display and a keyboard to facilitate operation of the tissue removal system, the ultrasound imaging system and the image display system from the same console.

RELATED APPLICATIONS

This application is related to provisional application Ser. No.60/810,906, filed on Jun. 5, 2006, which is incorporated herein in itsentirety and which is relied upon for priority.

FIELD OF THE INVENTION

This invention is directed to systems and methods for imaging andremoving tissue from a location within a patient and particularly to abiopsy system which has an integrated imaging system.

BACKGROUND OF THE INVENTION

Currently, to find suspicious areas or lesions, one or more imagingsystems are used to locate the area or lesion of interest and may beused to guide the biopsy probe of a biopsy systems to and/or near thearea or lesion of interest. Subsequently, tissue samples are removed andoften, particularly in the case of breast biopsy, markers are placed atthe site of the lesion removal.

Existing biopsy systems such as the EnCor® biopsy system manufactured bySenoRx, Inc. (the present assignee) and other commercially availablesystems are “stand alone” biopsy systems. Diagnostic imaging systemssuch as an ultrasound, x-ray, MRI, PET, CT, Thermal, etc. are separatedevices frequently requiring substantial. “floor space” in patienttreatment and/or diagnosis rooms in clinical settings such as clinicianoffices, breast centers, hospitals, etc. Portable imaging systems areavailable but they can require additional operators other than thephysician or other medical practitioner who is performing the biopsy.

SUMMARY OF THE INVENTION

A biopsy system embodying features of the invention includes a tissueremoval system, an imaging system, an image display system and a commoninput console for the tissue removal system, the imaging system and theimage display system.

The tissue removal system is suitable for use with one or more tissueremoval probes. The imaging system is preferably an ultrasonic imagingsystem. The imaging system is configured to display images taken by theimaging system. The common input console is configured for imputingcontrol or operational data to the tissue removal system, the imagingsystem and the image display system.

The tissue removal system has a programmable control module(microprocessor), at least one peripheral module for providing a vacuumto the tissue removal system and a plurality of connecting modulesconfigured to receive one or more tissue removing probes. The individualprobes preferably have software scripts stored in a memory device withinthe probe for operating the probe, controlling the functionalities ofthe probe and to provide pertinent information to the control modulewhen connected thereto.

The imaging system has a programmable control module (microprocessor)for controlling the imaging system providing imaging data to a maincomputer module for the image display system. Preferably the imagingsystem has a plurality of connecting modules which allow for use of aplurality of different imaging probes (e.g ultrasound probes). Forexample, the ultrasound probes may have different sized or differentshaped, e.g. flat or curved, ultrasonic transducer surfaces.

The biopsy system preferably has a main computer module which hascommunication links with the tissue removal system and the imagingsystem.

The common input console typically includes a key board and/or a touchscreen display which allows a single operator to handle the tissueremoval system the imaging system and the image display system.Moreover, the tissue removal system and the imaging system may be usedalone.

The biopsy system preferably has the tissue removal system, the imagingsystem and the image display system mounted on a movable base such as awheeled cart, so as to be easily transported to different locations. Thebiopsy system is small enough to provide a small foot-print in treatmentrooms.

A number of potential diagnostic ultrasound systems are availablecommercially that can be used in a biopsy system embodying features ofthe invention, including: Sonosite, Alora, Toshiba, Siemens, GE,Philips, Acuson, ATL, HP, Medison, Shimadzu, HDAC and Hitachi. Oneparticularly suitable ultrasound imaging system which can be packaged ina much smaller housing yet provides a high resolution, high imagequality capability that may be readily adaptable to a combined biopsysystem is available from the ULTRASONIX MEDICAL CORPORATION OF BRITISHCOLUMBIA (Burnaby) Canada. See www.ultrasonix.com. Details of theULTRASONIX imaging system can be found in the following patents andpublished applications which are incorporated herein in their entirety:U.S. Pat. No. 6,558,326 U.S. Pat. No. 6,911,008 U.S. Pat. No. 6,325,759U.S. Pat. Pub. No. 2002/000719 A1 U.S. Pat. Pub. No. 2004/0193047 A1U.S. Pat. Pub. No. 2004/0122314 A1

A particularly suitable tissue removal system is the EnCor® and SenoCor360® biopsy systems available from SenoRx, Inc. (the present assignee)of Aliso Viejo, Calif. Details of the EnCor® and SenoCor® biopsy systemscan be found in the following U.S. Patent and published applications:U.S. Pat. No. 6,620,157 U.S. Pat. Pub. No. 2004/0138653 U.S. Pat. Pub.No. 2005/0004559 U.S. Pat. Pub. No. 2005/0159677 U.S. Pat. Pub. No.2006/0149162See www.senorx.com for details of the EnCor®) and SenoCor 360® (biopsysystems.

With the present biopsy system the clinician can identify the outline ofthe ultrasound image and then determine the path of tissue removalprobe, e.g. an RF cutter or mechanical cutter (see listed publicationsand patents) on the image display. Additionally, the common inputconsole allows the clinician to input information to the tissue controlsystem, the imaging system and the image display system. These and otheradvantages will become more apparent from the following detaileddescription of embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a biopsy system which has a tissueremoval system and an ultrasonic imaging system embodying features ofthe invention.

FIG. 2 is a rear perspective view of the biopsy system shown in FIG. 1showing one side of the system.

FIG. 3 is a rear perspective view of the biopsy system shown in FIG. 1showing the side opposite to that shown in FIG. 2.

FIG. 4 is a side view of the biopsy system shown in FIG. 1.

FIG. 5 depicts a touch-display screen which allows operation of both thetissue removal system and the imaging system of the biopsy system shownin FIG. 1.

FIG. 6 is a general block diagram of a biopsy system embodying featuresof the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

FIGS. 1-5 illustrate a biopsy system 10 that embodies features of theinvention. The system 10 has a tissue removal system 11, an imagingsystem 12, display screen 13 and a common input console 14 with akeyboard 15 and a touch-screen display 16. The biopsy system 10 ismounted on a cart 17 which has wheels 18 at each corner for portability.The input console 14 has probe holders 20 for holding ultrasonic probesand tissue removal probes (not shown).

The tissue removal system 11 has connecting modules 21 and 22 that areconfigured to receive tissue removal probes (not shown) such as theprobes for EnCor® and SenoCor 360® probes which are available fromSenoRx, Inc., the present assignee. The imaging system 12 has connectingmodules 23, 24 and 25 for connecting with different suitable ultrasonicprobes, such as broadband transducers L 14-5/38, L 14-5W/60 and C 5-2/60available from Ultrasonix Medical Corporation. The first two are lineararray type transducers and the latter is a curved array type transducer.

FIG. 6 is a general block diagram of the biopsy system 10 shown in FIG.1 which has a tissue removal system 11, an ultrasonic imaging system 12and a main computer module 30 and an image display screen. The tissueremoval system 11 of system 10 has a tissue removal control module 31, avacuum module 32 for vacuum operations and tissue removal connectormodule 33 probe connectors 21 and 22. The vacuum module 32 has a vacuumline, a valve operated by the tissue removal control module 31 and avacuum source (e.g. a connection to a vacuum line or a vacuum pump)which are not shown. The imaging system 12 has an ultrasound controlmodule 34 for ultrasonic emission and reception and an interface withthe main computer module 30. An ultrasound connector module 35 is incommunication with the ultrasound control module and has ultrasoundprobe connectors 23, 24 and 25. Output from the main computer module 30related to the imaging input data thereto from the ultrasound controlmodule is directed through a communication link to the image displayscreen 13 to display ultrasonic diagnostic images from an ultrasonicprobe (not shown) connected to one of the ultrasound probe connectors23, 24 or 25.

The input console 14 is connected via a communication link to the maincomputer module 30 which in turn has communication links to the tissueremoval control module 31 and the ultrasound control module 34. Thisallows the single input console 14 to be employed to control both thetissue removal system 11 and the imaging system 12. The main displayscreen 13 is positioned right above the input console 14 so that asingle operator may easily operate both the tissue removal system 11 andthe ultrasound imaging system 12 from a single console. Further detailsof the tissue removal system can be found in patents and publishedapplications of SenoRx, Inc. previously referred to and incorporatedherein.

The ultrasound imaging system 12 for producing ultrasound images hasultrasound control module 34 is coupled to a ultrasound connector module35 has probe connectors 23, 24 and 24 to which may be connected anultrasound probe (not shown) The probe generates and receives acousticsignals. The acoustic signals that are generated by the probe aredirected towards a body region of a patient, e.g. breast, and some ofthe acoustic signals are reflected back to the probe as echo signals.The echo signals obtained by the probe are sent back to the ultrasoundcontrol module 34 which processes the echo signals to extract data thatis sent to the main computer module 30. The main computer module 30performs a display data processing in real-time which is sent to theultrasound display screen 13 where an ultrasound diagnostic image isdisplayed. See U.S. Pat. No. 6,325,759, for example, which isincorporated herein by reference. Input console 14 allows the user tointeract with the main computer module and modify the ultrasoundconfiguration. Further details of the ultrasound imaging system can befound in the patents and published applications of Ultrasonix previouslyreferred to and incorporated herein.

In the embodiment shown in FIG. 6, only the vacuum control module 32 andthe tissue removal control modules 32 are shown. However, additionalmodules may be provided, for example modules for a temperature probe, aheart rate monitor device, a drug infusion tools, anesthesia tools, orother surgical or medical devices that may operate with the biopsysystem 10. They may be connected to the tissue removal control module 31or directly to the main computer module 30. The tissue removal devicesconnected to the tissue removal connector module 33 may have mechanicaltissue cutting members or radio frequency (RF) powered electrosurgicalcutting members for performing the surgery. It is to be understood thatother peripheral modules can be of different forms and functions, andthey may not be required to be physically connected to the tissueremoval control module 31 or the ultrasound control module 34 ordirectly to the main computer module 30 so as to communicate therewith.

The tissue removal control module 31 is a microprocessor-basedelectrical device with built-in software functions necessary to operatevarious handheld devices for both tissue removal. Each handheld devicepreferably contains a software script, stored in a memory device withinthe handheld device, for operating that particular device when connectedto the tissue removal control module. For example, the said softwarescript may be stored in non-volatile memories such as erasableprogrammable read only memories (EPROMs), electrically erasableprogrammable read only memories (EEPROMs) or flash memories. When ahandheld device is indirectly connected to the tissue removal controlmodule 31, the software script within the handheld device will bedownloaded into the tissue removal control module. This software scriptwill enable the tissue removal control module 31 to control thefunctionalities of a particular handheld device. Connection to the maincomputer module 30 allows the touch screen 14 to display its pertinentinformation and allow control input through either the touch screen orthe keyboard 15. During the operation of a handheld device, a graphicaluser interface (GUI) software will display information on the touchscreen 14 relevant to the operation of the tissue removal control module31 and the handheld device to the operator. It is understood by thoseskilled in the art that the information displayed may vary dependingupon the type of handheld device connected, the operational state of thehandheld device as well as other environmental factors affecting theoperation of both the handheld device and the main computer module 30.

It is understood that although the various modules and the handhelddevices for either the tissue removal system 11 or the ultrasound imagesystem 12 may be interconnected through wired connections (includingconnector modules and wires) for their operations, the communicationlinks can be easily implemented through wireless communications.However, the conventional wired connections have certain advantages suchas low signal interferences, but the wireless technology can turn theoperation of the handheld device to a more mobile operation, whichbenefits the operator as well. For example, almost all the controlsignals can be sent through a predetermined wireless communicationchannel using technologies such as Bluetooth or 802.11 compliantwireless technologies. When the handheld device is battery powered, thenthe operation may be completely mobile. It is also practical that thewired communication channels may be used together with the wirelesscommunication channels so that the tissue removal control module cantake advantage of the available wireless technologies for providingconvenience to the operator, while still benefiting from using someconventional wired technologies. In short, while the examples providedherein illustrate embodiments having features of the invention, itshould be understood that communications between devices can takevarious forms and the main computer module 30, the tissue removalcontrol module 31 and the ultrasound control module 33 are designed touse the most practical technologies for fulfilling the need of theoperators.

The biopsy system may be powered by a single power source (not shown) orcan have multiple power sources for various functions. For example, thetissue removal system 11 and the ultrasound imaging system 12 may haveseparate power sources.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. For example, the discussionherein has focused on ultrasound imaging. Those having ordinary skill inthe art will recognize that other imaging systems may be employed, forexample x-ray or mammographic imaging. To the extent not previouslydescribed, the various elements of the biopsy system may be made fromconventional materials used in similar devices. Moreover, individualfeatures of embodiments of the invention may be shown in some drawingsand not in others, but those skilled in the art will recognize thatindividual features of one embodiment of the invention can be combinedwith any or all the features of another embodiment. Accordingly, it isnot intended that the invention be limited to the specific embodimentsillustrated. It is therefore intended that this invention be defined bythe scope of the appended claims as broadly as the prior art willpermit.

Terms such as “element”, “member”, “component”, “device”, “means”,“manufacture”, “portion”, “section”, “steps” and words of similar importwhen used herein shall not be construed as invoking the provisions of 35U.S.C. §112(6) unless the following claims expressly use the terms“means for” or “step for” followed by a particular function withoutreference to a specific structure or action. All patents and all patentapplications referred to above are hereby incorporated by reference intheir entirety.

1. A biopsy system, comprising: a. a main computer module; b. a tissueremoval system which has a tissue removal control module incommunication with the main computer module, a vacuum module incommunication with the tissue removal control module, a first connectormodule which is configured to form a first communication link between atissue removal probe and the tissue removal control module and a secondcommunication link between the vacuum control module and the tissueremoval control module; b. an ultrasonic imaging system which has aultrasound control module in communication with the main computermodule, a connector module configured to form a communication linkbetween an ultrasonic imaging probe and the ultrasonic control module;c. an image display screen in communication with the main computermodule configured to display an ultrasonic image display based upon datareceived from an ultrasound probe data and processed by the maincomputer module; and d. an input console in communication with the maincomputer module to provide control information for the ultrasoundcontrol module of the imaging system and to provide control informationfor the tissue removal control module of the tissue removal system. 2.The biopsy system of claim 1 wherein the main computer module has afirst communication link with the tissue removal control module and asecond communication with ultrasound control module to interchange datatherebetween.
 3. The biopsy system of claim 2 wherein the communicationlink between the main computer module and the tissue removal controlmodule is a serial cable.
 4. The biopsy system of claim 1 including aninterface module in communication between the ultrasound control moduleand the main computer module.
 5. The biopsy system of claim 1 whereinthe tissue removal system has a plurality of connector modules tofacilitate connecting different tissue removal probes to the tissueremoval system.
 6. The biopsy system of claim 1 wherein the imagingsystem has a plurality of connector modules to facilitate connectingdifferent ultrasound probes to the imaging system.
 7. The biopsy systemof claim 1 wherein the vacuum module has a vacuum line configured toengage the tissue removal probe and a flow control valve in the vacuumline which is controlled by the tissue removal control module to developa vacuum within a tissue removal probe connected to the connectingmodule for the tissue removal system.
 8. The biopsy system of claim 7wherein the vacuum module includes a vacuum source in communication withthe vacuum line.
 9. The biopsy system of claim 1 wherein the maincomputer module is a personal computer.
 10. The biopsy system of claim 1including a movable cart on which are mounted the tissue removal system,the ultrasound imaging system and the input console.
 11. The biopsysystem of claim 1 wherein the tissue removing system is contained withina first housing.
 12. The biopsy system of claim 1 wherein the ultrasoundimaging system is contained within a second housing.
 13. The biopsysystem of claim 1 wherein the ultrasonic imaging system and the tissueremoval system are operational simultaneously.
 14. The biopsy system ofclaim 1 including a movable platform.
 15. The biopsy system of claim 14wherein the platform has a plurality of wheels.
 16. The biopsy system ofclaim 14 wherein the platform has a housing to encase at least one ofthe tissue removal system or the ultrasound imaging system.
 17. Thebiopsy system of claim 16 wherein the housing encases the tissue removalsystem.
 18. The biopsy system of claim .16 wherein the housing encasesthe ultrasound imaging system.
 19. The biopsy system of claim 18 whereinthe main computer module is within the housing which encases theultrasound system.
 20. The biopsy system of claim 17 wherein the housingfor the tissue removal system encases the vacuum control module.
 21. Abiopsy system, comprising a movable base, a tissue removal system on themovable base, an imaging system on the movable base, an image displaysystem for displaying images taken by the imaging system and at leastone input console.
 22. The biopsy system of claim 21 wherein the inputconsole is a common input console for the tissue removal system and theimaging system
 23. The biopsy system of claim 21 wherein the tissueremoval system has a tissue removal control module, a tissue removalconnector module which is configured to form a first communication linkbetween a tissue removal probe and the tissue removal control module.24. The biopsy system of claim 23 wherein the tissue removal system hasa vacuum control module.
 25. The biopsy system of claim 24 wherein thetissue removal system has a second communication link between the vacuumcontrol module and the tissue removal control module.
 26. The biopsysystem of claim 21 wherein the imaging system is an ultrasound imagingsystem.
 27. The biopsy system of claim 26 wherein the ultrasound imagingsystem has a ultrasound control module, a connector module configured toform a communication link between an ultrasound imaging probe and theultrasound control module.
 28. The biopsy system of claim 27 wherein theimaging system has an image display screen configured to display anultrasound image based upon data received from an ultrasound probe. 29.The biopsy system of claim 28 wherein the common input console providescontrol information for the ultrasound control module of the imagingsystem and to provide control information for the tissue removal controlmodule of the tissue removal system.
 30. The biopsy system of claim 21including a main computer module having a communication link between thetissue removal control module and the ultrasound imaging control module.31. The biopsy system of claim 30 including a third communication linkbetween the main computer module and the tissue removal control module.32. The biopsy system of claim 31 including a fourth communication linkbetween the main computer module and the ultrasound control module. 33.The biopsy system of claim 31 wherein the communication link between themain computer module and the tissue removal control module is a serialcable.
 34. The biopsy system of claim 27 wherein the ultrasound imagingsystem includes an interface module in communication between theultrasound control module and the main computer module.
 35. The biopsysystem of claim 21 wherein the tissue removal system has a plurality ofconnector modules to facilitate connecting different tissue removalprobes to the tissue removal system.
 36. The biopsy system of claim 21wherein the imaging system has a plurality of connector modules tofacilitate connecting different imaging probes to the imaging system.37. The biopsy system of claim 24 wherein the vacuum module has a vacuumline configured to engage the tissue removal probe and a flow controlvalve in the vacuum line which is controlled by the tissue removalcontrol module to develop a vacuum within a tissue removal probeconnected to the connecting module for the tissue removal system. 38.The biopsy system of claim 24 wherein the vacuum module includes avacuum source in communication with the vacuum line.
 39. The biopsysystem of claim 21 wherein the movable base is a wheeled cart.
 40. Thebiopsy system of claim 21 wherein the tissue removing system iscontained within a first housing on the movable base.
 41. The biopsysystem of claim 21 wherein the imaging system is contained within asecond housing on the movable.
 42. The biopsy system of claim 21 whereinthe imaging system and the tissue removal system are operationalsimultaneously.
 43. The biopsy system of claim 41 wherein the maincomputer module is contained within the housing for the imaging system.44. The biopsy system of claim 40 wherein the vacuum control module iscontained within the housing for the tissue removal system.